The US Blood Transfusion Diagnostics Market : Effective Strategies for Vendors to Tackle the Decrease in Blood Supply Demand

March 2015

113 pages

Frost & Sullivan

Report ID: 2780387

Summary

Table of Contents

Methodology

The majority of the quantitative and qualitative information contained in this research service was acquired through primary research conducted with blood banking product providers. Most consultations were conducted with vice presidents (VPs) of business units, VPs of marketing, product managers, marketing managers, marketing directors, and business development directors from various competitors in the liquid handling market. Industry-specific information obtained includes:•Blood grouping and disease revenue breakdowns by product segments and regions•Company revenues, market share estimates, and projected growth rates of various competitors•Top-level customer, regional, and technology market trend information•Market drivers, restraints, and challenges Supplementary research was conducted utilizing secondary sources including scientific journals, online media, Frost & Sullivan databases and research services, and publicly available corporate filings. Forecasts are based on the data and analyses regarding industry challenges, market drivers and restraints, and market trends. If specific revenues or market sizes were unavailable, estimates were derived through consultations with industry experts, augmented by secondary research. Growth trends specific to certain market participants are based on consultations, past growth rates, and technology reviews.Key Findings

•The blood transfusion diagnostics market is mature, with estimated revenues of $ x million in 2014 and an expectation to reach $ x million by 2018. The growth for this period is an estimated x %.•Approximately x % of market sales arises from the blood grouping and typing segment and x % of comes from the disease screening (serological and NAT methods) segment. NAT methods are still evolving and contribute only x % to the disease screening market.•In the United States, this market is heavily impacted by demand for blood supply, and 2014 projected a decrease in blood supply in comparison to 2013.•However, given that approximately x % of the sites are still using manual methods for blood typing, this market has a huge scope for automation.•The molecular immunohematology segment is rising rapidly, particularly because hemagglutination methods are exhibiting problems. Considering the FDA has been quite slow in approving tests for IVD use, Immucor will dominate this market until its peers, such as Grifols, join the market in 2016.•Market mergers and acquisitions (M&A) have been slow; however, 2014 was marked by Novartis’s divestiture from transfusion and transplant diagnostics. As a result, Grifols was able to strengthen its presence in Europe and other countries by adding the acquired unit from Novartis’s business unit.•Slow improvements in new product innovation within the areas of blood typing and disease screening have led to a few interesting companies to watch. Quotient Diagnostics tops the list because of the extensive instrumentation capability to combine 3 applications into one single instrument.•It is also important to note that more instruments are cleared for diagnostic use outside the United States. For example, Europe has more CE IVD-approved instrument assays for serological- and NAT-based methods.•Supply chain is becoming an important component of blood banks, and several companies such as Haemonetics, Cerner, and Mediware are gaining importance. One of the persistent problems associated with automating the blood banking workflow is the interconnectivity with HIS and LIS applications.•Adding to this problem is the FDA’s emphasis on patient safety. This has slowed down the development of blood banking software and adversely affects companies such as Mediware and Psyche Systems that are actively participating in the blood banking software market.•CMS has increased the payment rates for certain blood services from 2013 to 2014 for services offered in a hospital outpatient setting. However, this increase in rates did not bring about any change in reimbursements for transfusion testing.•Cost for disease screening per NAT test dropped to an average of x % from 2012 to 2013. Frost & Sullivan expects further deductions in the price per test in 2015 as a result of clinical lab fee schedule and other sequestration measures across the diagnostics industry.

Scope and Segmentation

•The market covers two segments: blood grouping and disease screening.•The market includes only those platforms and reagents used in blood donor centers and those that are used to pre-test the quality of blood right before transfusion from the donor.•The market includes both automated and manual methods of testing.•Blood grouping includes instruments and reagents used for Abo and Rh testing, RBC antigen, and antibody identification and detection.•Disease screening includes serological detection and molecular methods of detection and assays.

Market Segmentation

The study accounts for ELISA, CLIA, and other immunoassay platforms for the donor blood transfusion diagnostics market. The scope also includes both manual and automated platforms and reagents. It is important that donor screening should not be confused with patient testing. In this study, research is focused on platforms and assays that are approved for donor testing only. For donor screening and testing the research covers only kits and platforms that can detect the following diseases in donor blood.•Serological tests: HBsAg, TPHA, Anti-HIV1/2, Anti-CMV, Anti HBc•NAT: HIV, HCV, HBV, HAV, Parvovirus B19•Each unit of blood is tested for red cell antibodies and infectious agents HIV-1, HIV-2, HTLV1/II, hepatitis C/B virus, West Nile virus, syphilis, and Chagas disease.

Key Questions This Study Will Answer

How is innovation changing the donor disease screening and blood grouping landscape?Are the products/services offered today meeting customer needs or is additional development needed?Will these products/services continue to exist, or will other companies acquire them?Are the vendors in the space ready to go it alone, or do they need partnerships to take their businesses to the next level?What was the trend in price for blood grouping and typing in 2012 and 2013? Has it increased or decreased?What was the trends in price for disease screening tests in 2012 and 2013? Has it increased or decreased?

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